Unique Device Identification: "The guideline obligates manufacturers to identify their products in a biunique manner"

Safety is the ultimate priority in medical technology. This also means that every single product and all batches have to be clearly identifiable and forgery-proof. The USA and Europe will make one step towards this goal in the following years: the marking with Unique Device Identification (UDI).

Sylvia Reingardt, branch manager health care at GS1 Germany, talks to COMPAMED.de about UDI. This guideline has the aim to unify marking of medical products worldwide. This will make it possible to trace a product back to its origin and to improve the processes throughout the supply chain – all the way from manufacturer to end user.

Sylvia Reingardt: UDI is a regulatory requirement, which is meant to globally regulate the standard identification of medical devices and in-vitro diagnostic devices. It was established by the U.S. Food & Drug Administration (FDA). The guideline obligates manufacturers to identify their products in a biunique manner. This does not just standardize the identification requirements for the different markets, but also supports patient safety and supply chain operations.

COMPAMED.de: What exactly does UDI look like?

Reingardt: Internal item numbers by manufacturers do not constitute unique identification. This is why UDI contains additional production data. This information is designed to be encoded in a barcode or data matrix, i.e., linear or two-dimensional data carriers and applied to the product packaging. Manufacturers must also supply all data on their products into a regulatory database.

COMPAMED.de: To what extent do products need to be identified? Does every small part get its own number?

Reingardt: From the FDA’s point of view, it is sufficient when the smallest package size a customer actually stocks is identified. However, there are exceptions: in the case of implants, the individual pieces have to be identified on the sterile outer packaging.

As an additional service, it would be possible for customers such as hospitals for instance to have manufacturers label other products individually. Material consumption could be better documented this way. Expensive products lend themselves to this. Certain intracardiac catheters for instance that are also in sterile individual packaging.

COMPAMED.de: To what extent is the implementation of UDI also going to increase patient safety?

Reingardt: When there is a product recall, the affected batches can be identified and located quicker. Presently in these cases at a hospital, all conceivable storage places have to be manually searched to find the batches. Time and cost play a role here. What’s more, there is a risk that not all storage units are being searched. Thanks to the barcode and automated control of goods received, this information is more quickly available.

COMPAMED.de: What information is contained in the barcode?

Reingardt: Aside from the unique item number, it needs to include everything that is already on the product label today: batch number, serial number, expiration data and similar information regarding production. This is the FDA requirement. The European Commission is expected to abide by this, but exactly how identification will ultimately look in Europe is presently still not certain.

COMPAMED.de: What processes are used for the identification?

Reingardt: This is primarily done through codes on the outer packaging. Originally, the FDA also requested direct marking for implants. However, manufacturers were very concerned that the marking could negatively affect material consistency. This regulation is temporarily suspended. However, direct marking is still required for multi-use products. Surgical instruments for instance consistently undergo sterile reprocessing. Depending on the material, different processes such as lasing or needling are an option for identification.

COMPAMED.de: What technical effort is required for suppliers and customers to become UDI compliant?

Reingardt: This largely depends on the existing infrastructure. We are also in contact with suppliers and manufacturers, who have never concerned themselves with marking and identification. They have to check whether their IT system is also able to manage the additional number. They also need label printers, and if required by their products, they also need to look into direct marking.

Purchasing scanners is not enough for hospitals. They need to be able to enter the identification numbers into their master data. To avoid a lot of manual labor in this case in the future, this should take place via electronic interfaces. This means however that they initially have to manage larger IT expenditures.

COMPAMED.de: How far along is UDI implementation in Europe and throughout the world?

Reingardt: Among other things, the exact implementation depends on the risk class for medical devices. Products with the high-risk Class III need to be UDI compliant within one year after the decision. The regulation went into effect on September 24, 2013 in the U.S. Starting September 24, 2014 products in Class III therefore must not be sold in the U.S without UDI identification. For medium-risk devices, this deadline is between two and three years and for low-risk devices five years.